OVAL: VB-111 and paclitaxel in patients with ovarian cancer - V6.1

• Research type

  Research Study

• Full title

  The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

• IRAS ID

  284967

• Contact name

  Michelle Lockley

• Contact email

  m.lockley@qmul.ac.uk

• Sponsor organisation

  Vascular Biogenics Ltd.

• Eudract number

  2019-003884-23

• Clinicaltrials.gov Identifier

  NCT03398655

• Duration of Study in the UK

  2 years, 1 months, 1 days

• Research summary

  This study is a Phase 3, double-blind, multicenter, randomized, controlled study to evaluate the efficacy, safety and tolerability of the combination of intravenous administration of Ofranergene Obadenovec (VB-111) and paclitaxel compared to placebo and paclitaxel in patients with platinum resistant ovarian cancer.

  This trial consists of 2 treatment arms, after an initial screening period, eligible participants will be randomly assigned (1:1) to one of two arms:

  (Arm 1) VB-111 (1x10^13 VPs) infused every 2 months combined with paclitaxel 80mg/m2 infused weekly
  (Arm 2) placebo infused every 2 months combined with paclitaxel 80mg/m2 infused weekly
  The cycle length will be 56 days. Patients will receive paclitaxel as a 60-minute IV infusion weekly. VB- 111/placebo will be administered as an IV infusion on Day 1 of each cycle.
  Within this trial the following investigational medicinal products will be tested:
  Ofranergene Obadenovec (VB-111) is an anti-angiogenic agent based on an adenovirus vector. It is a non-replicating E1 deleted, Adenovirus 5, carrying a pro-apoptotic human Fas-chimera (transgene) under the control of a modified murine promoter (PPE-1-3x). This virus has been modified genetically so it cannot reproduce and remain in the body. The transgene is specifically expressed in angiogenic endothelial cells. Moreover, the viral vector can stimulate the immune system, VB-111 induces infiltration of CD8 T-cells into the tumor, which is accompanied by apoptosis of tumor cells.
  •Paclitaxel is a standard chemotherapy drug that is already approved for use in recurrent ovarian cancer
  Periodically, patients will have a CT scan to check the effect of the treatment on the cancer. Patients will receive treatment until disease progression or withdrawal of consent or until unacceptable treatment-related toxicities. Follow-up assessments may continue for a maximum of 5 years after randomization.
  

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  21/SC/0069

• Date of REC Opinion

  30 Apr 2021

• REC opinion

  Further Information Favourable Opinion